Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]

Number of patients with symptomatic recurrent venous thromboembolic events [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]

All cause mortality [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]

Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]

Number of patients with other symptomatic thromboembolic events [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: Yes ]

Treatment satisfaction (patient reported outcomes) [ Time Frame: after approximately 2 years or 30 days after stop of therapy ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

Official Title ICMJE

Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)

Brief Summary

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.

Detailed Description

Not Provided

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: CohortTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

In- and outpatients in sites participating in the study

Condition ICMJE

Deep Vein Thrombosis

Venous Thrombosis

Intervention ICMJE

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban

Drug: Standard of care

Patients who will be treated for an acute deep vein thrombosis (DVT) with current standard of care comprising e.g. of initial treatment with low-molecular weight heparin or fondaparinux, followed by oral Vitamin-K antagonist for at least 3 months